Human Papillomavirus (HPV) DNA Detection with Genotyping, High-Risk Types by PCR, SurePath, Varies
Use
This test is useful for the detection of high-risk genotypes of human papillomavirus (HPV) associated with the development of cervical cancer. It aids in triaging women with abnormal Pap smear test results and provides individual genotyping of HPV-16 and/or HPV-18, if present. It's intended for use in clinical monitoring and management of patients but not for medical-legal applications.
Special Instructions
Not provided.
Limitations
The cobas HPV test is FDA-approved for cervical/endocervical samples collected in PreservCyt media. Other sample types, such as those collected in SurePath, are not FDA-approved, but verification studies met CLIA regulations. Prolonged storage in SurePath may affect HR-HPV detection, especially with low nucleic acid concentration. Specimens with whole blood over 10% in PreservCyt may yield false negatives. Only 14 high-risk genotypes are detected; low-risk types are not.
New York Approved
Methodology
PCR-based (Real-Time PCR)
Biomarkers
No genes
Gene
LOINC Codes
- 77378-8
- 31208-2
- 61372-9
- 61373-7
- 77375-4
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
3.0 mL
Minimum Volume
1 mL
Container
Cobas PCR Media Tube w/Cap
Collection Instructions
Aliquot 3 mL SurePath specimen into Cobas PCR Media Tube w/Cap tube. Bag specimens individually due to leakage risk. Place labels on the vial and on the bag.
Causes for Rejection
SurePath enriched cell pellet
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 42 days |
| Refrigerated | 42 days |